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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.53 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
176.32 mg/m³
Explanation for the modification of the dose descriptor starting point:

correction calculation: 200x (1/0.38) x (1/2) x (6.7/10)

AF for dose response relationship:
1
Justification:
NOAEL was used for DNEL derivation hence, AF of 1 was used for dose-response issues
AF for differences in duration of exposure:
4
Justification:
Based on the fact that NOAEL was derived from the Reproduction/Developmental Toxicity Screening Test ( OECD TG 421) the assessment factor of 4 was used (duration of the study was ca 50 days).
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not used for inhalation route.
AF for other interspecies differences:
2.5
Justification:
Additional factor of 2.5 for other interspecies differences was considered
AF for intraspecies differences:
5
Justification:
default assessment factor of 5 for workers was used
AF for the quality of the whole database:
1
Justification:
Based on the quality of data available, AF of 1 was used
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL was used for DNEL derivation hence, AF of 1 was used for dose-response issues
AF for differences in duration of exposure:
4
Justification:
Based on the fact that NOAEL was derived from the Reproduction/Developmental Toxicity Screening Test ( OECD TG 421) the assessment factor of 4 was used (duration of the study was ca 50 days).
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling rat to human
AF for other interspecies differences:
2.5
Justification:
Additional factor of 2.5 for other interspecies differences was considered
AF for intraspecies differences:
5
Justification:
default assessment factor of 5 for workers was used
AF for the quality of the whole database:
1
Justification:
Based on the quality of data available, AF of 1 was used
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.87 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
87 mg/m³
Explanation for the modification of the dose descriptor starting point:

correction calculation: 200 x (1/1.15) x (1/2)

AF for dose response relationship:
1
Justification:
NOAEL was used for DNEL derivation hence, AF of 1 was used for dose-response issues
AF for differences in duration of exposure:
4
Justification:
Based on the fact that NOAEL was derived from the Reproduction/Developmental Toxicity Screening Test ( OECD TG 421) the assessment factor of 4 was used (duration of the study was ca 50 days).
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
Additional factor of 2.5 for other interspecies differences was considered
AF for intraspecies differences:
10
Justification:
A default assessment factor of 10 was used, based on the fact that general population cover susceptible subgroups - the very young, the very old, and the very ill
AF for the quality of the whole database:
1
Justification:
Based on the quality of data available, AF of 1 was used
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL was used for DNEL derivation hence, AF of 1 was used for dose-response issues
AF for differences in duration of exposure:
4
Justification:
Based on the fact that NOAEL was derived from the Reproduction/Developmental Toxicity Screening Test ( OECD TG 421) the assessment factor of 4 was used (duration of the study was ca 50 days).
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor of 4 for allometric scalling from rat to human was used for dermal NOAEL
AF for other interspecies differences:
2.5
Justification:
Additional factor of 2.5 for other interspecies differences was considered
AF for intraspecies differences:
10
Justification:
A default assessment factor of 10 was used, based on the fact that general population cover susceptible subgroups - the very young, the very old, and the very ill
AF for the quality of the whole database:
1
Justification:
Based on the quality of data available, AF of 1 was used
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL was used for DNEL derivation hence, AF of 1 was used for dose-response issues
AF for differences in duration of exposure:
4
Justification:
Based on the fact that NOAEL was derived from the Reproduction/Developmental Toxicity Screening Test ( OECD TG 421) the assessment factor of 4 was used (duration of the study was ca 50 days).
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor of 4 for allometric scalling from rat to human was used
AF for other interspecies differences:
2.5
Justification:
Additional factor of 2.5 for other interspecies differences was considered
AF for intraspecies differences:
10
Justification:
A default assessment factor of 10 was used, based on the fact that general population cover susceptible subgroups - the very young, the very old, and the very ill
AF for the quality of the whole database:
1
Justification:
Based on the quality of data available, AF of 1 was used
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population